Kawasaki Disease

(Methylprednisolone vs Placebo Trial)

Study Summary

This study evaluated steroid therapy in Kawasaki disease (KD).

Before this study started, the standard treatment for KD included a single high dose of intravenous gammaglobulin (IVIG) and aspirin. While the majority of children respond well to this treatment, some developed coronary artery aneurysms.

The purpose of this trial was to see if adding steroids (methylprednisone) to the standard treatment would improve coronary artery outcomes. 199 children participated in the study.

199 Children

Participated in this study.

Steroid Therapy Did Not Improve Outcomes

Adding a single dose of IV steroids to the standard treatment for KD did not improve coronary artery outcomes, adverse events or total hospital or fever days.

Coronary Artery Aneurysms Rare in Both Groups

Coronary artery aneurysms were rare in both groups of patients in this study.

Who was in the study?

Children with KD within the first 10 days of illness onset.

What happened during the study?

Each qualified child was randomly assigned to one of two treatment groups. One group received the standard care (gammaglobulin (IVIG) and aspirin) and the other group received the standard care plus a single dose of steroids. Patients who still had fever >36 hours after the first IVIG treatment were given a second treatment with IVIG. A medical history review was done and the following tests were done upon entry to the study, at 1 week after entry and 5 weeks after entry into the study:

  • Echocardiogram
  • Blood sample
  • Weight and height measurements
  • Recording of any events that happened during the illness

What were the results of the study?

The numbers of coronary artery aneurysms were rare but similar between the two treatment groups. The two groups also had similar rates of mitral regurgitation, total number of days of fever and total number of days in the hospital.

There was no significant difference in the number of patients who needed a second treatment with IVIG. The group that received steroids had some blood tests that indicated less inflammation at 1 week and 5 weeks after treatment, but most lab tests were the same in the two groups. Adverse events were similar in the two groups.

In conclusion, adding a single dose of IV steroids to the standard treatment for KD does not improve coronary artery outcomes, adverse events or total hospital or fever days. Therefore, steroid treatment is not indicated in the initial treatment of KD.

Study Publications

  • Randomized Trial of Pulsed Corticosteroid Therapy for Primary Treatment of Kawasaki Disease

    J. Newburger, N Engl J Med 2007; 356(7):663-675.

    Children with Kawasaki Disease (KD) are at risk for developing aneurysms (out-pouchings) and enlargement of the coronary arteries, the arteries which bring blood and oxygen to the heart muscle itself. Medications are used to reduce the risk of damage to the coronary arteries and to decrease inflammation. Yet, some children still develop aneurysms and coronary artery enlargement. This trial tested whether adding another type of medication (a corticosteroid) to the standard treatment of aspirin and immune globulin would decrease the amount of coronary artery dilation. The results did not support the use of a steroid in addition for the routine treatment of children with KD.

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  • Treatment of Kawasaki Disease: Response to Letter to the Editor

    J. Newburger, N Engl J Med 2007; 356(26):2748.

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  • Delayed Diagnosis of Kawasaki Disease: What Are the Risk Factors?

    L. Minich, Pediatrics 2007; 120(6):e1434-40.

    Late diagnosis of Kawasaki Disease (KD) increases the risk that a child might have enlargement or aneurysms (out-pouching) of their coronary arteries. This study tried to see how many children in the KD study had a late diagnosis and what factors contributed to a late diagnosis. Being less than 6 months of age, living a greater distance from the hospital and having fewer symptoms (incomplete KD) increased the likelihood of late diagnosis.

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  • Coronary Artery Involvement in Children with Kawasaki Disease: Risk Factors from Analysis of Serial Normalized Measurements

    B. McCrindle, Circulation 2007; 116:1-6.

    This study looked at how coronary artery size changes during when a child has Kawasaki Disease (KD) by performing echocardiograms at the time of diagnosis, at one week and five weeks after diagnosis. The results showed that, in most patients, the coronary arteries are most dilated at the time of diagnosis of KD and they decrease in size over time. The KD study also showed that aneurysms (bulges or outpouches) in the coronary arteries were infrequent.

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  • Associated Symptoms in the Ten Days Before Diagnosis of Kawasaki Disease

    A. Baker, J Pediatr 2009; 154(4):592-595.

    Many children with Kawasaki disease (KD) have other symptoms that may lead to a delay in the diagnosis of KD. This study investigated common symptoms in children in the KD study (in addition to the symptoms of KD) in the 10 days before they were diagnosed with KD. Symptoms reported were irritability, vomiting, decrease in food/fluid intake, coughing, diarrhea, runny nose, weakness, stomach pain, and joint pain. Symptoms of KD can often be accompanied by symptoms commonly found in other common childhood illnesses. Clinicians should consider the diagnosis of KD, even when other common symptoms are present.

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  • Non-Coronary Cardiac Abnormalities are Associated with Coronary Artery Dilation and with Laboratory Inflammatory Markers in Acute Kawasaki Disease

    B. Printz, J Am Coll Cardiol 2011; 57:86-92.

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  • Evaluation of Kawasaki Disease Risk Scoring Systems for Intravenous Immunoglobulin Resistance

    L. Sleeper, J Pediatr 2011; 158:831-5.

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  • Predictors of coronary artery visualization in Kawasaki disease

    R. Margossian, J Am Soc Echocardiogr 2011; 24(1):53-9.

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